Cleared Traditional

K873277 - MITRAFLEX(TM) WOUND DRESSING (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K873277 · Matrix Medica, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
31d
Days
Class 1
Risk

K873277 is an FDA 510(k) clearance for the MITRAFLEX(TM) WOUND DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Matrix Medica, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on September 17, 1987 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Matrix Medica, Inc. devices

Submission Details

510(k) Number K873277 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 17, 1987
Decision Date September 17, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 114d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.